ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fingolimod

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Interventions

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Fingolimod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects aged 18-65 years
* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
* Interferon-beta (IFN-β) treatment for at least 18 months.
* Positive IFN-NAb titer at screening or within 6 months prior to screening
* Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

Exclusion Criteria

* patients with previous or current disease of immune system
* active infections
* cardiovascular risk patients
* Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No